Safety and Effectiveness of Pulsed Field Ablation for Atrial Fibrillation in Patients with Heart Failure: A MANIFEST-PF Sub-analysis.

BACKGROUND: Atrial fibrillation (AF) and heart failure (HF) coexist, increasing morbidity and mortality. Studies have demonstrated improved outcomes following AF ablation in HF patients with reduced ejection fraction (EF). OBJECTIVE: To assess the outcomes of pulsed-field ablation (PFA) in HF. METHODS: MANIFEST-PF is a multicenter patient-level registry of consecutive patients undergoing PFA for paroxysmal (PAF) or persistent AF (PerAF). In this sub-study, patients were stratified as: no history of HF (no-HF), HF with preserved EF (HFPEF; LVEF≥50%) or HF with reduced/mildly-reduced EF (HFMR/REF; LVEF<50%). The primary effectiveness and safety endpoints were freedom from documented atrial arrhythmias lasting ≥30s and major adverse events (MAEs), respectively. RESULTS: Of the 1,381 patients, 85% (n=1,174) were no-HF, 6.2% (n=87) were HFPEF, and 8.6% (n=120) were HFMR/REF. No-HF patients had less PerAF than patients with HF (p<0.001), with no difference between HF subtypes (p=1.00). The 1-year freedom from atrial arrhythmia was significantly higher in no-HF than with HFPEF or HFMR/REF (79.9%, 71.3%, 67.5%, p<0.001), but similar between HFMR/REF and HFPEF (p=0.26). However, there was no significant difference in freedom from atrial arrhythmia among patients with no-HF vs HFPEF vs HFMR/REF for those with PAF (82.8%/82.4%/71.7%, p=0.09) and PerAF (73.3%, 64.2%, and 64.9%, p=0.14.MAE rates were similar between the no-HF, HFPEF and HFMR/REF groups (1.9%, 0%, and 2.5%, respectively). CONCLUSION: PFA appears to be potentially safe and effective in AF patients with HF. Freedom from atrial arrhythmia post-PFA was higher in patients without a history of HF, with no significant difference between HF subtypes.

Safety and Effectiveness of Pulsed Field Ablation for Atrial Fibrillation in Patients With Heart Failure.

BACKGROUND: Atrial fibrillation (AF) and heart failure (HF) coexist, increasing morbidity and mortality. Studies have demonstrated improved outcomes following AF ablation in HF patients with reduced ejection fraction (EF). OBJECTIVE: This study sought to assess the outcomes of pulsed field ablation (PFA) in HF. METHODS: MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-Approval Clinical Use of Pulsed Field Ablation) is a multicenter, patient-level registry of consecutive patients undergoing PFA for paroxysmal AF or persistent AF (PerAF). In this substudy, patients were stratified as no history of HF (no-HF), HF with preserved EF (HFpEF) (left ventricular EF of ≥50%) or HF with reduced/mildly reduced EF (HFmr/rEF) (left ventricular EF of <50%). The primary effectiveness and safety endpoints were freedom from documented atrial arrhythmias lasting ≥30 seconds and major adverse events, respectively. RESULTS: Of the 1,381 patients, 85% (n = 1,174) were no-HF, 6.2% (n = 87) were HFpEF, and 8.6% (n = 120) were HFmr/rEF. No-HF patients had less PerAF than patients with HF (P < 0.001), with no difference between HF subtypes (P = >0.99). The 1-year freedom from atrial arrhythmia was significantly higher in no-HF patients than in those with HFpEF or HFmr/rEF (79.9%, 71.3%, and 67.5%, respectively; P < 0.001) but similar between patients with HFmr/rEF and HFpEF (P = 0.26). However, there was no significant difference in freedom from atrial arrhythmia among patients with no-HF vs HFpEF vs HFmr/rEF for those with paroxysmal AF (82.8%, 82.4%, and 71.7%, respectively; P = 0.09) and PerAF (73.3%, 64.2%, and 64.9%, respectively; P = 0.14). Major adverse event rates were similar between the no-HF, HFpEF, and HFmr/rEF groups (1.9%, 0%, and 2.5%, respectively). CONCLUSIONS: PFA appears to be potentially safe and effective in AF patients with HF. Freedom from atrial arrhythmia post-PFA was higher in patients without a history of HF, with no significant difference between HF subtypes.

Impact of Left Atrial Posterior Wall Ablation During Pulsed-Field Ablation for Persistent Atrial Fibrillation.

BACKGROUND: Pulmonary vein isolation (PVI) alone is insufficient to treat many patients with persistent atrial fibrillation (PersAF). Adjunctive left atrial posterior wall (LAPW) ablation with thermal technologies has revealed lack of efficacy, perhaps limited by the difficulty in achieving lesion durability amid concerns of esophageal injury. OBJECTIVES: This study aims to compare the safety and effectiveness of PVI + LAPW ablation vs PVI in patients with PersAF using pulsed-field ablation (PFA). METHODS: In a retrospective analysis of the MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-approval Clinical Use of Pulsed Field Ablation) registry, we studied consecutive PersAF patients undergoing post-approval treatment with a pentaspline PFA catheter. The primary effectiveness outcome was freedom from any atrial arrhythmia of ≥30 seconds. Safety outcomes included the composite of acute and chronic major adverse events. RESULTS: Of the 547 patients with PersAF who underwent PFA, 131 (24%) received adjunctive LAPW ablation. Compared to PVI-alone, patients receiving adjunctive LAPW ablation were younger (65 vs 67 years of age, P = 0.08), had a lower CHA2DS2-VASc score (2.3 ± 1.6 vs 2.6 ± 1.6, P = 0.08), and were more likely to receive electroanatomical mapping (48.1% vs 39.0%, P = 0.07) and intracardiac echocardiography imaging (46.1% vs 17.1%, P < 0.001). The 1-year Kaplan-Meier estimate for freedom from atrial arrhythmias was not statistically different between groups in the full (PVI + LAPW: 66.4%; 95% CI: 57.6%-74.4% vs PVI: 73.1%; 95% CI: 68.5%-77.2%; P = 0.68) and propensity-matched cohorts (PVI + LAPW: 71.7% vs PVI: 68.5%; P = 0.34). There was also no significant difference in major adverse events between the groups (2.2% vs 1.4%, respectively, P = 0.51). CONCLUSIONS: In patients with PersAF undergoing PFA, as compared to PVI-alone, adjunctive LAPW ablation did not improve freedom from atrial arrhythmia at 12 months.

Epicardial ventricular tachycardia ablation: safety and efficacy of access and ablation using low-iodine content.

BACKGROUND: Epicardial ablation has become an integral part of the treatment of ventricular tachycardias (VT). This study reports the safety of epicardial access as well as the efficacy of epicardial ablation of structural heart disease in a tertiary single-center experience. METHODS: Between January 2016 and February 2022, consecutive patients undergoing an epicardial access for VT ablation were included. Different puncture techniques and occurrence of epicardial access-related complications as well as the safety of ablation using non-ionic 5% dextrose in water (D5W) compared to standard 0.9% normal saline (NS) irrigation were analyzed. VT recurrence rates during a mean follow-up of 37 ± 23 months were reported. RESULTS: In total, 197 patients undergoing a total of 239 procedures were included (59.8 ± 15.3 years, 86% males). A total of 154 patients (78%) had non-ischemic cardiomyopathies with a mean LVEF of 37 ± 14. Anterior-oriented epicardial access was aimed for in all cases and was successful in 217 (91%) of all procedures, whereas access was achieved in 19 procedures (8%) only using an inferior oriented access and in three procedures (1%) using surgical access due to severe adhesions or anatomical requirements. Overall epicardial puncture-related complications occurred in 18 (8%) of all procedures with minor pericardial bleeding in nine, pericardial tamponade in one, pneumothorax in five, pneumopericardium in one, and abdominal puncture in two cases. Presence of adhesions could be identified as the only independent predictor of epicardial access-related complications. D5W was used in 79 cases and regular 0.9% saline in 117 procedures. No differences were seen regarding acute ablation success or complications. During follow-up, 47% of all patients were free from any VTs (56% D5W vs. 40% NS; log-rank p = 0.747) and 92% of clinical VTs (98% D5W vs. 91% NS; log-rank p = 0.139). CONCLUSIONS: In this large single-centre experience, epicardial access and ablation were safe and feasible. Although long-term clinical VT recurrence rates were low, overall VT recurrences as well as mortality were high advocating for a highly experienced, interdisciplinary approach including intense management of underlying cardiac disease/heart failure. Routine usage of D5W was safe and associated with comparable short- or long-term clinical or overall VT freedom.

Clinical Outcomes by Sex After Pulsed Field Ablation of Atrial Fibrillation.

Importance: Previous studies evaluating the association of patient sex with clinical outcomes using conventional thermal ablative modalities for atrial fibrillation (AF) such as radiofrequency or cryoablation are controversial due to mixed results. Pulsed field ablation (PFA) is a novel AF ablation energy modality that has demonstrated preferential myocardial tissue ablation with a unique safety profile. Objective: To compare sex differences in patients undergoing PFA for AF in the Multinational Survey on the Methods, Efficacy, and Safety on the Postapproval Clinical Use of Pulsed Field Ablation (MANIFEST-PF) registry. Design, Setting, and Participants: This was a retrospective cohort study of MANIFEST-PF registry data, which included consecutive patients undergoing postregulatory approval treatment with PFA to treat AF between March 2021 and May 2022 with a median follow-up of 1 year. MANIFEST-PF is a multinational, retrospectively analyzed, prospectively enrolled patient-level registry including 24 European centers. The study included all consecutive registry patients (age ≥18 years) who underwent first-ever PFA for paroxysmal or persistent AF. Exposure: PFA was performed on patients with AF. All patients underwent pulmonary vein isolation and additional ablation, which was performed at the discretion of the operator. Main Outcomes and Measures: The primary effectiveness outcome was freedom from clinically documented atrial arrhythmia for 30 seconds or longer after a 3-month blanking period. The primary safety outcome was the composite of acute (<7 days postprocedure) and chronic (>7 days) major adverse events (MAEs). Results: Of 1568 patients (mean [SD] age, 64.5 [11.5] years; 1015 male [64.7%]) with AF who underwent PFA, female patients, as compared with male patients, were older (mean [SD] age, 68 [10] years vs 62 [12] years; P < .001), had more paroxysmal AF (70.2% [388 of 553] vs 62.4% [633 of 1015]; P = .002) but had fewer comorbidities such as coronary disease (9% [38 of 553] vs 15.9% [129 of 1015]; P < .001), heart failure (10.5% [58 of 553] vs 16.6% [168 of 1015]; P = .001), and sleep apnea (4.7% [18 of 553] vs 11.7% [84 of 1015]; P < .001). Pulmonary vein isolation was performed in 99.8% of female (552 of 553) and 98.9% of male (1004 of 1015; P = .90) patients. Additional ablation was performed in 22.4% of female (124 of 553) and 23.1% of male (235 of 1015; P = .79) patients. The 1-year Kaplan-Meier estimate for freedom from atrial arrhythmia was similar in male and female patients (79.0%; 95% CI, 76.3%-81.5% vs 76.3%; 95% CI, 72.5%-79.8%; P = .28). There was also no significant difference in acute major AEs between groups (male, 1.5% [16 of 1015] vs female, 2.5% [14 of 553]; P = .19). Conclusion and Relevance: Results of this cohort study suggest that after PFA for AF, there were no significant sex differences in clinical effectiveness or safety events.

Recurrent Atrial Fibrillation Ablation after Initial Successful Pulmonary Vein Isolation.

BACKGROUND: Pulmonary vein isolation (PVI) is an effective treatment option for patients with symptomatic atrial fibrillation (AF). However, the electrical recovery of pulmonary veins (PVs) is the main trigger for AF recurrences. This study investigates the characteristics of patients admitted for redo AF ablation, the PV reconnection rates depending on previous ablation modalities and the impact of different ablation strategies for redo procedures. METHODS: Consecutive patients undergoing first redo AF ablation were included. Patients were grouped according to the electrical recovery of at least one PV. The impacts of the technique for first AF ablation on PV reconnection rates and patients with and without PV reconnection were compared. Different ablation strategies for redo procedures were compared and its recurrence rates after a mean follow-up of 25 ± 20 months were investigated. RESULTS: A total of 389 patients (68 ± 10 years; 57% male; 39% paroxysmal AF) underwent a first redo. The median time between the first and redo procedure was 40 ± 39 months. Radiofrequency was used in 278 patients, cryoballoon was used in 85 patients and surgical AF ablation was performed on 26 patients. In total, 325 patients (84%) had at least one PV reconnected, and the mean number of reconnected PVs was 2.0 ± 1.3, with significant differences between ablation approaches (p for all = 0.002); this was mainly due to differences in the left inferior PV and right superior PV reconnections. The presence of PV reconnection during redo was not associated with better long-term success compared to completely isolated PVs (67% vs. 67%; log-rank p = 0.997). Overall, the different ablation strategies for redos were comparable regarding AF recurrences during follow-up (p = 0.079), with the ablation approach having no impact in the case of left atrial low voltage or without. CONCLUSIONS: PV reconnections after initial successful PVI are common among all techniques of AF ablation. Long-term rhythm control off antiarrhythmic drugs was possible in 2/3 of all patients after the redo procedure; however, different ablation strategies with extra-PV trigger ablation did not improve long-term success. Patients with recurrent AF after PVI constitute a challenging group of patients.

Safety and Effectiveness of Pulsed Field Ablation to Treat Atrial Fibrillation: One-Year Outcomes From the MANIFEST-PF Registry.

BACKGROUND: Pulsed field ablation is a novel nonthermal cardiac ablation modality using ultra-rapid electrical pulses to cause cell death by a mechanism of irreversible electroporation. Unlike the traditional ablation energy sources, pulsed field ablation has demonstrated significant preferentiality to myocardial tissue ablation, and thus avoids certain thermally mediated complications. However, its safety and effectiveness remain unknown in usual clinical care. METHODS: MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-Approval Clinical Use of Pulsed Field Ablation) is a retrospective, multinational, patient-level registry wherein patients at each center were prospectively included in their respective center registries. The registry included all patients undergoing postapproval treatment with a multielectrode 5-spline pulsed field ablation catheter to treat atrial fibrillation (AF) between March 1, 2021, and May 30, 2022. The primary effectiveness outcome was freedom from clinical documented atrial arrhythmia (AF/atrial flutter/atrial tachycardia) of ≥30 seconds on the basis of electrocardiographic data after a 3-month blanking period (on or off antiarrhythmic drugs). Safety outcomes included the composite of acute (<7 days postprocedure) and latent (>7 days) major adverse events. RESULTS: At 24 European centers (77 operators) pulsed field ablation was performed in 1568 patients with AF: age 64.5±11.5 years, female 35%, paroxysmal/persistent AF 65%/32%, CHA2DS2-VASc 2.2±1.6, median left ventricular ejection fraction 60%, and left atrial diameter 42 mm. Pulmonary vein isolation was achieved in 99.2% of patients. After a median (interquartile range) follow-up of 367 (289-421) days, the 1-year Kaplan-Meier estimate for freedom from atrial arrhythmia was 78.1% (95% CI, 76.0%-80.0%); clinical effectiveness was more common in patients with paroxysmal AF versus persistent AF (81.6% versus 71.5%; P=0.001). Acute major adverse events occurred in 1.9% of patients. CONCLUSIONS: In this large observational registry of the postapproval clinical use of pulsed field technology to treat AF, catheter ablation using pulsed field energy was clinically effective in 78% of patients with AF.

Electrical Storm Has Worse Prognosis Compared to Sustained Ventricular Tachycardia after VT Ablation.

BACKGROUND: Electrical storm (ES) represents a serious heart rhythm disorder. This study investigates the impact of ES on acute ablation success and long-term outcomes after VT ablation compared to non-ES patients. METHODS: In this large single-centre study, patients presenting with ES and undergoing VT ablation from June 2018 to April 2021 were compared to patients undergoing VT ablation due to ventricular tachyarrhythmias but without ES. The primary prognostic outcome was VT recurrence, and secondary endpoints were rehospitalization rates and cardiovascular mortality, all after a median follow-up of 22 months. RESULTS: A total of 311 patients underwent a first VT ablation due to ventricular tachyarrhythmias and were included (63 ± 14 years; 86% male). Of these, 108 presented with ES. In the ES cohort, dilated cardiomyopathy as underlying heart disease was significantly higher (p = 0.008). Major complications were equal across both groups (all p > 0.05). Ablation of the clinical VT was achieved in 94% of all patients (p > 0.05). Noninducibility of any VT was achieved in 91% without ES and in 76% with ES (p = 0.001). Patients with ES revealed increased VT recurrence rates during follow-up (65% vs. 40%; log rank p = 0.001; HR 1.841, 95% CI 1.289-2.628; p = 0.001). Furthermore, ES patients suffered from increased rehospitalization rates (73% vs. 48%; log rank p = 0.001; HR 1.948, 95% CI 1.415-2.682; p = 0.001) and cardiovascular mortality (18% vs. 9%; log rank p = 0.045; HR 1.948, 95% CI 1.004-3.780; p = 0.049). After multivariable adjustment, ES was a strong independent predictor of VT recurrence and rehospitalization rates, but not for mortality. In a propensity score-matched cohort, patients with ES still had a higher risk of VT recurrences and rehospitalizations compared to non-ES patients. CONCLUSIONS: VT ablation in patients with ES is challenging and these patients reveal the highest risk for recurrent VTs, rehospitalization and cardiovascular mortality. These patients need close follow-ups and optimal guideline-directed therapy.

Acute oesophageal safety and long-term follow-up of AI-guided high-power short-duration with 50 W for atrial fibrillation ablation.

AIMS: Pulmonary vein isolation using radiofrequency ablation is an effective treatment option for patients with symptomatic atrial fibrillation (AF). Application of high power over a short period of time (HPSD) is reported to create more efficient lesions and may prevent collateral thermal oesophageal injury. This study aims to compare efficacy and safety of two different HPSD ablation approaches using different ablation index settings. METHODS AND RESULTS: Consecutive patients undergoing AF ablation with HPSD (50 W; ablation index-guided) using the ThermoCool SmartTouch SF catheter were included. Patients were grouped by ablation protocol: ablation with target ablation index (AI) of 400 on the anterior left atrial wall vs. 300 at the posterior left atrial wall (AI 400/300) or AI 450/350 was performed upon the operator's preference and compared. Peri-procedural parameters and complications were recorded, and incidences of endoscopically detected thermal oesophageal lesions (EDEL) analysed. Recurrence rates after a mean follow-up of 25 ± 7 months and reconnection patterns in patients undergoing redo procedures were investigated. A total of 795 patients (67 ± 10 years; 58% male; 48% paroxysmal AF) underwent a first AF ablation with HPSD (211 in group AI 400/300 and 584 in group 450/350). Median procedure time was 82.9 ± 24.6 min with longer ablation times in patients with target AI 400/300 due to higher intraprocedural reconnection rates, increased box lesions, and additional right atrial isthmus ablations. EDEL rates among target AI 400/300 procedures were significantly lower (3% vs. 7%; P = 0.019). Correspondingly, AI 450/350 was the strongest independent predictor of post-ablation EDEL (OR 4.799, CI 1.427-16.138, P = 0.011). Twelve-month (76% vs. 76%; P = 0.892) and long-term ablation single procedure success (68% vs. 71%; log-rank P = 0.452) after a mean of 25 ± 7 months were comparable among both target AI groups; however, long-term success was significantly higher for paroxysmal AF compared to persistent AF (12 months: 80% vs. 72%; P = 0.010; end of follow-up: 76% vs. 65%; log-rank P = 0.001). One hundred three patients (16%) underwent a redo procedure during follow-up documented comparable pulmonary vein (PV) reconnection among groups. Multivariate predictors of AF recurrence were age, left atrium (LA) size, persistent AF, and extra-PV ablation targets. CONCLUSION: High-power short-duration AF ablation with target AI of 400 for non-posterior wall and 300 for posterior wall lesions resulted in comparable long-term results compared to higher AI (450/350) ablations with significantly lower risk for thermal oesophageal lesions. Older age, larger LA size, persistent AF, and extra-PV ablation targets were identified in a multivariate analysis as independent risk factors for recurrences of atrial arrhythmias.

Adverse Prognosis of Patients With Septal Substrate After VT Ablation Due to Electrical Storm.

BACKGROUND: Data about ventricular tachycardia (VT) ablation in patients with electrical storm (ES) is limited. OBJECTIVES: This study sought to compare the prognostic outcome of patients undergoing VT ablation after ES with and without a septal substrate. METHODS: In this large single-center study, consecutive patients presenting with ES and undergoing VT ablation from June 2018 to April 2021 were included. Patients with septal substrate were compared with patients without septal substrate regarding endpoints of cardiovascular mortality, VT recurrences, recurrences of the clinical VT, and rehospitalization rates. RESULTS: A total of 107 patients undergoing a first VT ablation because of electrical storm (ES) were included (age 65 ± 13 years, 86% male, 45% ischemic cardiomyopathy). Major complications occurred in 11% of all patients with increased postinterventional third-degree atrioventricular blocks among patients with septal substrate (9% vs 0%; P = 0.063). Partial ablation successes were similar (95% with a septal substrate vs 100% without a septal substrate; P = 0.251). Complete ablation success was achieved in 63% with a septal substrate and in 87% without a septal substrate (P = 0.004). After a median 22 months of follow-up, patients with septal substrate died significantly more often from cardiovascular causes (26% vs 7%; log-rank P = 0.018). In univariate analysis cardiovascular mortality for ES patients with septal substrate was 4.1-fold higher (HR: 4.192; CI: 1.194-14.719; P = 0.025). Independent predictors of adverse outcome in multivariable regression analysis were presence of septal substrate (HR: 5.723; P = 0.025) and increased age (HR: 1.104; P = 0.003). Recurrences of any ventricular arrhythmia (67% vs 56%; log rank P = 0.554) and rehospitalization rates (80% vs 66%; log rank P = 0.515) were similar between groups. Recurrences of clinical VT were similar (7% vs 2%; P = 0.252). CONCLUSIONS: Presence of a septal substrate is associated with adverse long-term cardiovascular mortality in patients admitted for VT ablation after ES. Despite decreased acute ablation successes in these patients, VT recurrence rates were similar to those without a septal substrate during follow-up.

Radiofrequency ablation of atrial fibrillation-50 W or 90 W?

BACKGROUND: This study sought to evaluate the short and midterm efficacy and safety of the novel very high power very short duration (vHPvSD) 90 W approach compared to HPSD 50 W for atrial fibrillation (AF) ablation as well as reconnection patterns of 90 W ablations. METHODS AND RESULTS: Consecutive patients undergoing first AF ablation with vHPvSD (90 W; predefined ablation time of 3 s for posterior wall ablation and 4 s for anterior wall ablation) were compared to patients using HPSD (50 W; ablation index-guided; AI 350 for posterior wall ablation, AI 450 for anterior wall ablation) retrospectively. A total of 84 patients (67.1 ± 9.8 years; 58% male; 47% paroxysmal AF) were included (42 with 90 W, 42 with 50 W) out of a propensity score-matched cohort. 90 W ablations revealed shorter ablation times (10.5 ± 6.7 min vs. 17.4 ± 9.9 min; p = .001). No major complication occurred. 90 W ablations revealed lower first pass PVI rates (40% vs. 62%; p = .049) and higher AF recurrences during blanking period (38% vs. 12%; p = .007). After 12 months, both ablation approaches revealed comparable midterm outcomes (62% vs. 70%; log-rank p = .452). In a multivariable Cox regression model, persistent AF (hazard ratio [HR]: 1.442, 95% confidence interval [CI]: 1.035-2.010, p = .031) and increased procedural duration (HR: 1.011, 95% CI: 1.005-1.017, p = .001) were identified as independent predictors of AF recurrence during follow-up. CONCLUSIONS: AF ablation using 90 W vHPvSD reveals a similar safety profile compared to 50 W ablation with shorter ablation times. However, vHPvSD ablation was associated with lower rates of first-pass isolations and increased AF recurrences during the blanking period. After 12 months, 90 W revealed comparable efficacy results to 50 W ablations in a nonrandomized, propensity-matched comparison.

Optimal cut-off value for endocardial bipolar voltage mapping using a multipoint mapping catheter to characterize the scar regions described in cardio-CT with myocardial thinning.

INTRODUCTION: To investigate whether the current standard voltage cut-off of <0.5 for dense scar definition on endocardial bipolar voltage mapping (EBVM), using a high-resolution multipoint mapping catheter with microelectrodes (HRMMC), correctly identifies the actual scar area described on CT with myocardial thinning (CT MT). METHODS: Forty patients (39 men; 67.0 ± 9.0 y/o) with a history of transmural myocardial infarction (mean time interval since MI 15.0 ± 7.9 years) and sustained ventricular tachycardia (VT) were consecutively enrolled. A CT MT was performed in each patient before VT ablation. The CT MT 3D anatomical model, including MT layers, was merged with the 3D electroanatomical and EBVM. Different predefined cut-off settings for scar definition on EBVM were used to identify the optimal ones, which showed the best overlap in terms of scar area with the different MT layers. RESULTS: A cut-off value of <0.2 mV demonstrated the best correlation in terms of scar area with the 2 mm thinning on CT MT (p = .04) and a cut-off of <1 mV best overlapped with the 5 mm thinning (p = .003). The currently used <0.5 mV cut-off for scar definition on EBVM proved to be the best area correlation with 3 mm thinning (p = .0002). CONCLUSION: In order to better identify the real extent of scar areas after transmural MI as described on preprocedural CT MT, higher cut-off values for scar definition should be applied if the EBVM is performed using a HRMMC.

Long-Term Outcomes after Catheter Ablation of Ventricular Tachycardia in Dilated vs. Ischemic Cardiomyopathy.

Ischemic (ICM) and dilated cardiomyopathy (DCM) represent the two main underlying heart diseases in patients referred for catheter ablation of ventricular tachycardia (VT). While VT ablation in ischemic cardiomyopathy is relatively well-studied, data in patients with DCM are still scarce. The study aimed to compare the acute and long-term outcomes in patients with ICM and DCM who underwent VT ablation at a high-volume center. Consecutive patients who underwent VT ablation from April 2018 to April 2021 were included retrospectively. Patients with ischemic cardiomyopathy were compared to those with dilated cardiomyopathy. The primary endpoint was rate of VT recurrences, the secondary endpoints included overall mortality, rehospitalization because of cardiac condition (VT, acute heart failure, acute myocardial infarction, heart transplantation or implantation of left ventricular assisting device), and major adverse cardiac events (MACE) at long-term follow-up. A total of 225 patients admitted for first VT ablation were included. A total of 156 patients (69%) revealed ICM and 69 (31%) DCM. After a mean follow-up of 22 months, the primary endpoint of VT recurrence occurred significantly more often in the patients with dilated cardiomyopathy (ICM n = 47; 37% vs. DCM n = 34; 64%; p = 0.001). In regard to the secondary endpoint of overall mortality, there was no difference between the two patient cohorts (DCM n = 9; 15% vs. ICM n = 22; 16%; p = 0.677); the patients with DCM showed significantly higher rehospitalization rates due to cardiac conditions (75% vs. 59%; p = 0.038) and more frequent MACE (68% vs. 52%; p= 0.036). In a Cox regression model, electrical storm at admission was shown to be a predictor for VT recurrence after successful catheter ablation (HR = 1.942: 95% CI 1.237-3.050; p = 0.004), while the ablation of every induced VT morphology during the procedure (HR = 0.522; 95% CI = 0.307-0.885; p = 0.016) contributed to a positive long-term outcome. DCM is associated with a higher risk of VT recurrence after catheter ablation compared to ICM. Furthermore, patients with DCM are more frequent re-hospitalized in the majority of cases due the VT recurrence. There is no difference in the long-term mortality between the two cohorts.

Empirical superior vena cava isolation in patients undergoing repeat catheter ablation procedure after recurrence of atrial fibrillation.

BACKGROUND: Although the ectopic foci responsible for initiating atrial fibrillation (AF) are usually located in the pulmonary veins (PVs), non-PV sources may initiate AF in approximately 11% of unselected patients with paroxysmal or persistent AF. The superior vena cava (SVC) is one of the most frequent non-PV origins for initiating AF. This study aims to investigate the effect of empirical SVC isolation in redo AF ablation procedures. METHODS: Consecutive patients undergoing redo AF ablation procedures using a high-power short-duration protocol (HPSD) (50 W; ablation index guided; target AI 350 for posterior wall ablation, AI 450 for anterior wall ablation; CARTO 3 mapping system) were included. Patients with SVC isolation were compared to patients without SVC isolation. Periprocedural parameters and complications were recorded and analyzed. Short-term endpoints included intrahospital AF recurrence, midterm endpoint AF freedom after 3 months, and long-term endpoint AF freedom after 12 months. RESULTS: A total of 276 patients underwent repeat ablation for recurrent AF (67 ± 10 years; 57% male; 31.5% paroxysmal AF). The patients were divided into two groups: redo procedures with SVC isolation vs redo procedure without SVC isolation. Additional LA substrate modification was done based on intraprocedural voltage maps. Baseline characteristics did not differ significantly between the two groups. Median procedure time was 85.4 ± 27.1 min with ablation times of 14.0 ± 8.5 min. Intrahospital AF recurrence occurred in 32 patients (12%) with no difference among both groups: 17 patients (13%) SVC vs 15 patients (10%) No-SVC; p = 0.416. At 3-month follow-up, 47 (17%) presented an AF recurrence during the blanking period: 25 patients (19%) SVC vs 22 patients (15%) No-SVC; p = 0.304). After 12 months, 202 (73%) of all patients were in stable sinus rhythm with no significant difference between the two groups: 93 patients (73%) SVC vs 109 patients (74%) No-SVC; p = 0.853). No significant differences were noted when dividing the patients in paroxysmal or persistent AF with and without SVC isolation. CONCLUSIONS: In our series of repeat AF ablation procedures, the addition of empirical SVC isolation to Re-PVI and LA substrate modification did not influence AF recurrence rates. This strategy can however be safe and useful in patients in whom SVC is identified as a trigger of AF.

Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF).

AIMS: Pulsed field ablation (PFA) is a novel atrial fibrillation (AF) ablation modality that has demonstrated preferential tissue ablation, including no oesophageal damage, in first-in-human clinical trials. In the MANIFEST-PF survey, we investigated the 'real world' performance of the only approved PFA catheter, including acute effectiveness and safety-in particular, rare oesophageal effects and other unforeseen PFA-related complications. METHODS AND RESULTS: This retrospective survey included all 24 clinical centres using the pentaspline PFA catheter after regulatory approval. Institution-level data were obtained on patient characteristics, procedure parameters, acute efficacy, and adverse events. With an average of 73 patients treated per centre (range 7-291), full cohort included 1758 patients: mean age 61.6 years (range 19-92), female 34%, first-time ablation 94%, paroxysmal/persistent AF 58/35%. Most procedures employed deep sedation without intubation (82.1%), and 15.1% were discharged same day. Pulmonary vein isolation (PVI) was successful in 99.9% (range 98.9-100%). Procedure time was 65 min (38-215). There were no oesophageal complications or phrenic nerve injuries persisting past hospital discharge. Major complications (1.6%) were pericardial tamponade (0.97%) and stroke (0.4%); one stroke resulted in death (0.06%). Minor complications (3.9%) were primarily vascular (3.3%), but also included transient phrenic nerve paresis (0.46%), and TIA (0.11%). Rare complications included coronary artery spasm, haemoptysis, and dry cough persistent for 6 weeks (0.06% each). CONCLUSION: In a large cohort of unselected patients, PFA was efficacious for PVI, and expressed a safety profile consistent with preferential tissue ablation. However, the frequency of 'generic' catheter complications (tamponade, stroke) underscores the need for improvement.

Case report: Epicardial ligation of the left atrial appendage in a patient with an inaccessible left atrial cavity.

It has been shown that endocardial occlusion of the left atrial appendage (LAA) is equally effective in preventing embolic events compared to oral anticoagulation in patients with nonvalvular atrial fibrillation. An 82-year-old female patient was admitted for LAA occlusion for repetitive GI bleeding. She had high CHADSVASC Score and HASBLED with long persistent atrial fibrillation with many comorbities. The preprocedural transesophageal echo revealed a great mass in the left atrium (Picture 1). Cardiac surgery was denied, we performed an epicardial only ligation for closing the LAA. For this approach we performed an epicardial puncture and contrast injection within the pericardial space to delineate the LAA. An epicardial wire with a suction mechanism at its distal end was attached to the anterior lobe of the LAA. Using this epicardial wire the snare could be advanced over the appendage and closed down. Complete exclusion of the LAA was achieved. There were no procedural complications and the patient is doing well after 3 months.

[Relevant anatomy of epicardial space for the electrophysiologists]. / Relevante Anatomie des epikardialen Raums für Elektrophysiologen.

The arrhythmogenic substrate in patients with Chagas cardiomyopathy, arrhythmogenic dysplasia, postmyocarditis nonischemic dilative cardiomyopathy as well as after extensive posterior or anterior wall myocardial infarction is predominantly located epicardially. This can necessitate epicardial access for an effective, substrate-based catheter ablation of the ventricular tachycardia (VT). Anterior percutaneous epicardial puncture represents the standard approach for epicardial VT ablation. The most important anatomical particularities that must be taken into account when performing an epicardial puncture or epicardial VT ablation are epicardial coronary arteries, left phrenic nerve and epicardial fat. The typical anatomic characteristics of the epicardial structures and resulting considerations for epicardial access are discussed here in detail.

Efficacy and safety of high-power short duration atrial fibrillation ablation in elderly patients.

INTRODUCTION: Data about atrial fibrillation (AF) ablation using high-power short duration (HPSD) radiofrequency ablation in the elderly population is still scarce. The aim of our study was to investigate the efficacy and safety of HPSD ablation in patients over 75 years compared to younger patients. METHODS: Consecutive patients older than 75 years with paroxysmal or persistent AF undergoing a first-time AF ablation using 50 W HPSD ablation approach were analyzed in this retrospective observational analysis and compared to a control group <75 years. Short-term endpoints included intraprocedural reconnection of at least one pulmonary vein (PV) and intrahospital and AF recurrence during 3 months blanking period, as well as a long-term endpoint of freedom from atrial arrhythmias of antiarrhythmic drugs after 12 months. RESULTS: A total of 540 patients underwent a first AF ablation with HPSD (66 ± 10 years; 58% male; 47% paroxysmal AF). Mean age was 78 ± 2.4 and 63 ± 6.3 years (p < .001), respectively. Elderly patients were significantly more often women (p < .001). The procedure, fluoroscopy, and ablation were comparable. Elderly patients revealed significantly more often extra-PV low-voltage areas requiring additional left atrial ablations (p < .001). Overall complication rates were low; however, elderly patients revealed higher major complication rates mainly due to unmasking sick sinus syndrome (p = .003). Freedom from arrhythmia recurrences was comparable (68% vs. 76%, log-rank p = .087). Only in the subgroup of paroxysmal AF, AF recurrences were more common after 12 months (69% vs. 82%; log-rank p = .040; hazard ratio: 1.462, p = .044) in the elderly patients. In multivariable Cox regression analysis of the whole cohort persistent AF, female gender, diabetes mellitus and presence of left atrium low-voltage areas, but not age >75 years were associated with AF recurrences. CONCLUSION: HPSD AF ablation of patients >75 years in experienced centers is safe and effective. Therefore, age alone should not be the reason to withhold AF ablation from vital elderly patients due to only a slightly worse outcome and safety profile. In paroxysmal AF, elderly patients have more recurrences compared to the younger control group.

Safety aspects of very high power very short duration atrial fibrillation ablation using a modified radiofrequency RF-generator: Single-center experience.

INTRODUCTION: High power short duration (HPSD) ablation proved to be an effective and safe ablation technique for atrial fibrillation (AF). In former case series, a significant amount of postablation coagulation at the catheter tip as well as silent cerebral lesions (SCL) in postprocedural cerebral magnetic resonance (cMRI) have been identified in patients undergoing de-novo AF ablations with very high power 90 W short duration (vHPvSD) ablations using the QDot ablation catheter in combination with a novel RF generator (nGEN, Biosense Webster). Therefore, the RF generator software has been recently modified. METHODS AND RESULTS: Consecutive patients undergoing a first AF ablation including pulmonary vein isolation (PVI) with vHPvSD (90 W, with a predefined ablation time of 3 s at posterior left atrium (LA) wall sites and 4 s at other ablation sites) using the QDOT Micro ablation catheter (Biosense Webster) in conjunction with the technically modified nGEN RF generator (software V1c; Biosense Webster) were included. Procedural characteristics including first-pass isolation per pulmonary vein (PV) pair and early reconnection location within the 30-min waiting period were recorded. In all patients postablation endoscopy to document any thermal esophageal injury (EDEL) and in eligible patients a cMRI to detect silent cerebral events (SCEs)/lesions were performed. All acute procedure-related complications were recorded during the time until hospital discharge. Furthermore, short-term and midterm success after 3 and 6-12 months of follow-up was investigated. In total, 34 consecutive patients (67 ± 9 years; 62% male; 68% paroxysmal AF) were included. First-pass isolation of all PVs was achieved in 6/34 (18%) patients. First-pass isolation was seen in 37/68 (54%) of PV pairs. Early reconnection occurred in 11 (32%) patients (including reconnections at posterior LA wall sites n = 6 and at nonposterior sites n = 5). No patient had an EDEL (0%). In 6/23 (26%) patients undergoing postablation cerebral MRI SCEs were identified. In six patients, coagulation on the catheter tip was detected at the end of the procedure. No further peri- or postprocedural complications were detected. Early AF recurrence before discharge was seen in 1/34 (3%) of the patients included in this study. Within 3 months 10/34 (29%) revealed AF recurrence during blanking period. After a mean follow-up of 7 months, 31/34 (88%) patients revealed sinus rhythm. CONCLUSION: AF ablation using 90 W vHPvSD with a specialized ablation catheter in conjunction with a recently modified RF generator was associated with no EDEL in the whole study cohort and 26% SCEs in a subgroup of patients undergoing acute postablation cerebral MRI. Accordingly, to our previously published results, a relevant number of catheter tip coagulations was identified in this patient cohort even after modifications of the RF generator. The vHPvSD ablation technique using the present and the previous generator seems to be associated with a very low rate of esophageal injury. However, the recently revised generator software also produced a relevant number of catheter tip coagulum formation and SCEs.

Acute oesophageal safety of high-power short duration with 50 W for atrial fibrillation ablation.

AIMS: Pulmonary vein isolation (PVI) using radiofrequency (RF) ablation is an effective treatment option for patients with atrial fibrillation (AF). This study aims to investigate the safety of high-power short duration (HPSD) with emphasis on oesophageal lesions after PVI. METHODS AND RESULTS: Consecutive patients undergoing AF ablation with HPSD (50 W; ablation index (AI)-guided; target AI 350 for posterior wall ablation, AI 450 for anterior wall ablation) using the ThermoCool SmartTouch SF catheter were included. Patients underwent post-ablation oesophageal endoscopy to detect and categorize thermal oesophageal injury (EDEL). Occurrence and risk factors of oesophageal lesions and perforating complications were analysed. A total of 1033 patients underwent AF ablation with HPSD. Of them, 953 patients (67.6 ± 9.6 years; 58% male; 43% paroxysmal AF; 68% first PVI) underwent post-procedural oesophageal endoscopy and were included in further analyses. Median procedure time was 82.8 ± 24.4 min with ablation times of 16.1 ± 9.2 min. Thermal oesophageal injury was detected in 58 patients (6%) (n = 29 Category 1 erosion, n = 29 Category 2 ulcerous). One patient developed oesophageal perforation (redo, 4th AF ablation). No patient died. Using multivariable regression models, increased total ablation time [odds ratio (OR) 1.029, P = 0.010] and history of stroke (OR 2.619, P = 0.033) were associated with increased incidence of EDEL after AF ablation, whereas increased body mass index was protective (OR 0.980, P = 0.022). CONCLUSION: Thermal oesophageal lesions occur in 6% of HPSD AF ablations. The risk for development of perforating complications seems to be low. Incidence of atrio-oesophageal fistula (0.1%) is comparable to other reported series about RF ablation approaches.